Real-world experience with doxorubicin and olaratumab in soft tissue sarcomas in England and Northern Ireland.
Chemotherapy
Doxorubicin
Olaratumab
Soft tissue sarcomas
Journal
Clinical sarcoma research
ISSN: 2045-3329
Titre abrégé: Clin Sarcoma Res
Pays: England
ID NLM: 101577890
Informations de publication
Date de publication:
2020
2020
Historique:
received:
21
01
2020
accepted:
25
04
2020
entrez:
12
5
2020
pubmed:
12
5
2020
medline:
12
5
2020
Statut:
epublish
Résumé
A randomised phase II trial demonstrated that the addition of olaratumab to doxorubicin significantly increased overall survival (OS) in patients with advanced soft tissue sarcomas (STS) compared to doxorubicin alone. The recently presented phase III study of doxorubicin and olaratumab in advanced soft tissue sarcoma was discordant with this finding. We performed a retrospective analysis of adult patients with advanced-/metastatic STS treated with at least two cycles of doxorubicin and olaratumab at eight sarcoma units across England and Northern Ireland between May 2017 and March 2019. 172 patients were evaluable and 40 patients (23.3%) had died at the time of analysis. Median ECOG performance status (PS) was 1. Median progression free survival (PFS) was 6.8 months (95% CI 5.9-7.7 months). Leiomyosarcoma was the most common histological subtype (75 patients, 43.6%), followed by liposarcomas (19, 11.0%). The mean number of cycles was 5 (doxorubicin range 2-6; olaratumab range 2-23). Two patients (1.2%) had a complete response and 34 (19.8%) had a partial response. 79 (45.9%) had stable and 58 (33.7%) progressive disease. 57 patients (33.1%) experienced grade ≥ 3 neutropenia and 7 patients (4.1%) grade ≥ 3 febrile neutropenia. Grade ≥ 3 anaemia was seen in 21 patients (12.2%). Grade ≥ 3 non-haematological toxicities were seen in 35 patients (20.3%). A clinically significant drop in left ventricular ejection fraction was seen in 6 patients (3.5%). 48 patients (27.9%) required a dose reduction. Overall survival (OS) is pending. Our results are in keeping with the phase III study findings: response rate, PFS and OS were similar to those reported in the phase III ANNOUNCE trial.
Sections du résumé
BACKGROUND
BACKGROUND
A randomised phase II trial demonstrated that the addition of olaratumab to doxorubicin significantly increased overall survival (OS) in patients with advanced soft tissue sarcomas (STS) compared to doxorubicin alone. The recently presented phase III study of doxorubicin and olaratumab in advanced soft tissue sarcoma was discordant with this finding.
METHODS
METHODS
We performed a retrospective analysis of adult patients with advanced-/metastatic STS treated with at least two cycles of doxorubicin and olaratumab at eight sarcoma units across England and Northern Ireland between May 2017 and March 2019.
RESULTS
RESULTS
172 patients were evaluable and 40 patients (23.3%) had died at the time of analysis. Median ECOG performance status (PS) was 1. Median progression free survival (PFS) was 6.8 months (95% CI 5.9-7.7 months). Leiomyosarcoma was the most common histological subtype (75 patients, 43.6%), followed by liposarcomas (19, 11.0%). The mean number of cycles was 5 (doxorubicin range 2-6; olaratumab range 2-23). Two patients (1.2%) had a complete response and 34 (19.8%) had a partial response. 79 (45.9%) had stable and 58 (33.7%) progressive disease. 57 patients (33.1%) experienced grade ≥ 3 neutropenia and 7 patients (4.1%) grade ≥ 3 febrile neutropenia. Grade ≥ 3 anaemia was seen in 21 patients (12.2%). Grade ≥ 3 non-haematological toxicities were seen in 35 patients (20.3%). A clinically significant drop in left ventricular ejection fraction was seen in 6 patients (3.5%). 48 patients (27.9%) required a dose reduction. Overall survival (OS) is pending.
CONCLUSIONS
CONCLUSIONS
Our results are in keeping with the phase III study findings: response rate, PFS and OS were similar to those reported in the phase III ANNOUNCE trial.
Identifiants
pubmed: 32391141
doi: 10.1186/s13569-020-00131-x
pii: 131
pmc: PMC7203838
doi:
Types de publication
Journal Article
Langues
eng
Pagination
9Informations de copyright
© The Author(s) 2020.
Déclaration de conflit d'intérêts
Competing interestsSpyridon Gennatas: None, Florence Chamberlain: None, Thomas Carter: None, Susanna Slater: None, Elena Cojocaru: None, Beth Lambourne: None, Anna Stansfeld: None, Radha Todd: None, Mark Verrill: None, Nasim Ali: None, Robin L Jones: Receipt of honoraria and consultation fees (Adaptimmune; Blueprint; Clinigen; Eisai; Epizyme; Daichii; Deciphera; Immunedesign; Lilly; Merck; Pharmamar), Peter Simmonds: None, Nicola Keay: None, Heather McCarty: None, Sandra Strauss: None, Vassilios Karavasilis: None, Palma Dileo: None, Charlotte Benson: None.
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